BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO

    MDR report key: 9000794 · Received September 11, 2019

    Report

    Report Number
    9615742-2019-03099
    Event Type
    Injury
    Date Received
    September 11, 2019
    Report Date
    September 11, 2019
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521101425
    PMA / PMN Number
    K915526
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA BY OPEN REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRING HERNIA, ABDOMINAL AND GROIN PAIN, INFLAMMATORY CHANGES, SWELLING AND PROTRUSION OF THE HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. MEDICAL RECORDS NOTED THAT THE PATIENT HAD BEEN NONCOMPLIANT WITH FOLLOW UP CARE INSTRUCTIONS. THE PRODUCT HAD BEEN USED WITH A BARD PERFIX PLUG, LOT: HUBQ0347, PRODUCT ID: 0112780.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794148 SURGIPRO MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS SPMM-35 A5J1088WX 10884521101425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention